Osteoporosis vertebral fracture Musculoskeletal Diseases Osteoporosis with pathological fracture
Conditions
Interventions
Following baseline assessment and registration participants will be individually randomised (1:1) between either: Opt-In (OsteoPorosis Tailored exercise adherence INtervention) programme or usual phys
making sure that participants are allocated to treating physiotherapists delivering the treatment for their allocated arm.
Due to the nature of the intervention, blinding the participant to their all
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who had a diagnosis of primary osteoporosis confirmed by a radiograph or dual energy X-ray absorptiometry (DEXA) scan (=2.5 standard deviation below the norm) at the lowest lumbar level 2. Patients who had a history of at least one symptomatic osteoporotic vertebral fracture (OVF) 3. Patients aged =18 years 4. Patients who were postmenopausal (if female) 5. Patients able to walk =10 m independently with or without an aid 6. Patients able to understand and participate in the physiotherapy programme
Exclusion criteria
Exclusion criteria: 1. Patients aged <18 years 2. Patients who had osteoporosis secondary to other metabolic bone disorders or disease (e.g. rheumatoid arthritis, cancer and osteomalacia), experienced lower-limb joint surgery, or fracture, in the previous 6 months 3. Patients whose primary problem was back pain with pain radiating into the lower limb 4. Patients who had undergone vertebroplasty, facet joint injection or any physical therapy (e.g. chiropractic, osteopathic or physiotherapeutic treatment for back pain in the previous 12 weeks) 5. Patients with severe unstable cardiovascular or pulmonary disease or significant psychiatric or neurological conditions that would preclude participation in the physiotherapy treatment arms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Balance, lower limb strength and walking ability measured using the Timed Up and Go (TUG) at baseline, 4, 8 and 12 months with the main end point of 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 4, 8 and 12 months with the main end point of 12 months: 1. Health-related quality of life (QoL) measured using QUALEFFO 41 2. Shoulder and back muscle endurance measured using Timed Loaded Standing (TLS) 3. Thoracic kyphosis angle measured non-radiographically using a flexicurve ruler 4. Back pain measured with a 10-point Numeric Pain Rating Scale (NPRS) 5. Dynamic standing balance measured using the Functional Reach (FR) test 6. Functional walking capacity and aerobic cardio-respiratory fitness measured using the six-minute walk (6MW) test 7. Fear or concern about falling during activities measured using the Falls Efficacy Scale International (FES-I) 8. Grip strength measured with an isometric hand dynamometer 9. Self-efficacy for exercise measured using the Self-Efficacy for Exercise (SEE) scale 10. Adherence measured using: 10.1. Attendance records via clinician completed treatment logs, including a checkbox to log whether adherence techniques have been prescribed (intervention group only) 10.2. Exercise adherence rating scale (EARS) | — |
Countries
England, United Kingdom
Outcome results
None listed